search
Back to results

Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant (PROACTIVE)

Primary Purpose

Leukemia, Lymphoma, Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHAMPS-II adapted to adults 60+ years in HCT setting
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Hematopoietic cell transplantation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Arm 1:

Inclusion Criteria for Participants:

  • age 60 years and older
  • have a diagnosis of hematological malignancy
  • have received autologous or allogeneic HCT within the prior 3-6 months
  • able to speak and read English
  • have provided written informed consent

Exclusion Criteria for Participants:

  • there are no exclusion criteria

Inclusion Criteria for Participants' Care-Partner:

  • age 19 years and older
  • able to speak and read English

Exclusion Criteria for Participants' Care-Partner:

  • there are no exclusion criteria

Inclusion Criteria for Transplant Team Member:

  • age 19 years and older
  • able to speak and read English

Exclusion Criteria for Transplant Team Member:

  • there are no exclusion criteria

Arms 2 and 3:

Inclusion Criteria for Participants:

  • age 60 years and older
  • have a diagnosis of hematological malignancy
  • planned to receive an autologous or allogeneic HCT
  • able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
  • (In Arm 3 only): willingness to be randomized to either the physical activity intervention or survivorship education active control condition, and to follow the protocol for the group to which they have been assigned
  • able to speak and read English
  • have provided written informed consent

Exclusion Criteria for Participants:

  • development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
  • is not cleared to participate in exercise by a physician

Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:

  • Myocardial infarctions in the past 3 months
  • Resting or unstable angina
  • Uncontrolled and/or serious arrhythmias
  • 3rd degree heart block
  • Acute congestive heart failure or ejection fraction <30%
  • Clinically significant aortic stenosis

Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:

o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months

  • other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition

Inclusion Criteria for Participants' Care-Partner:

  • age 19 years and older
  • able to speak and read English
  • able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
  • have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form

Exclusion Criteria for Participants' Care-Partner:

  • development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
  • is not cleared to participate in exercise by a physician

Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:

  • Myocardial infarctions in the past 3 months
  • Resting or unstable angina
  • Uncontrolled and/or serious arrhythmias
  • 3rd degree heart block
  • Acute congestive heart failure or ejection fraction <30%
  • Clinically significant aortic stenosis

Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:

o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months

  • other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition

Inclusion Criteria for Transplant Team Member:

  • age 19 years and older
  • able to speak and read English

Exclusion Criteria for Transplant Team Member:

  • there are no exclusion criteria

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Feedback for Preliminary Adaptation

Adapted CHAMPS-II intervention

Arm Description

Participants in Aim 1 will participate in qualitative interviews to obtain feedback on the CHAMPS-II intervention and survivorship education active control condition materials. Interviews will be with 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members.

All participants in Aim 2 (preliminary testing) and Aim 3 (RCT) will participate in the CHAMPS-II physical activity program adapted to the HCT setting. Testing for outcome measures will be completed, and feedback on the intervention will be obtained via qualitative interviews from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members. Aim 3 participants will be randomized to either the immediate intervention (intervention then follow-up) or delayed intervention (wait period and then intervention).

Outcomes

Primary Outcome Measures

Change in executive function as measured by Trails A.
Change in raw scores and z-scores, determined by the following neuropsychological test: Trail Making Test Part A (Trails A). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Change in executive function as measured by Trails B.
Change in raw scores and z-scores, determined by the following neuropsychological tests: Trail Making Test Part B (Trails B). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Change in executive function as measured by the Controlled Oral Word Association Test (COWAT).
Change in raw scores and z-scores, determined by the following neuropsychological test: Controlled Oral Word Association Test (COWAT). Minimum score is zero and maximum is unlimited; higher score means better outcome.
Change in working memory as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Change in raw scores and z-scores, determined by the following neuropsychological test: Hopkins Verbal Learning Test-Revised (HVLT-R). There are 3 learning trials and 1 delayed recall trial. Minimum score for each is zero and maximum is 12; higher score means better outcome. There is also a delayed recognition trial where person is presented with both true positives and false positives. Minimum score for both is zero and maximum is 12. For the true positives a higher score means better outcome. For the false positives a lower score means better outcome.

Secondary Outcome Measures

Change in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA).
Change in total score, determined by objective measures of global cognitive function using the Montreal Cognitive Assessment (MoCA). Minimum score is zero and maximum is 30; higher score means better outcome.
Change in subjective memory as measured by the Neuro-Quality of Life (QOL) Cognition Function-Short Form.
Change in total score, determined by patient questionnaire: Neuro-Quality of Life (QOL) Cognition Function-Short Form. Minimum score is 8 and maximum score is 40; higher score means better outcome.

Full Information

First Posted
May 7, 2021
Last Updated
September 29, 2023
Sponsor
University of Nebraska
search

1. Study Identification

Unique Protocol Identification Number
NCT04898790
Brief Title
Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant
Acronym
PROACTIVE
Official Title
Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cancer and treatment-related cognitive changes hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Physical activity improves cognitive function in older adults and survivors of other cancers. We hypothesize that increasing physical activity can also improve cognitive function in this vulnerable population. The objective of this research is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 60 years and older. Aim 1: Adapt the CHAMPS-II manual and develop study materials using feedback from up to 10 patient/care-partner dyads who have experienced the HCT process within the last 3-6 months and HCT team members via semi-structured interviews. Aim 2: Iteratively adapt and implement CHAMPS-II intervention in three waves (2-6 patient/care-partner dyads per wave). The dyads will participate in a multi-phase, light to moderate-intensity physical activity program through Day 100 post-HCT. Aim 3: Test the preliminary effectiveness of the adapted intervention to improve cognitive function compared to a wait-list control condition (N = 34 per group) in a 2-arm, pilot randomized controlled trial. Primary and secondary outcomes will include subjective and objective cognitive function using a short battery of neuropsychological tests and a self-report questionnaire. Tertiary outcomes comprise subjective and objective measures of physical activity behavior and physical function. The RE-AIM framework will be utilized for formative and process evaluation during the adaptation process and implementation of the intervention.
Detailed Description
Hematologic malignancies are diseases that primarily affect older adults, with a median age at diagnosis of 65 years. Hematopoietic cell transplantation (HCT) is a potentially curative and life-prolonging treatment for patients with hematologic malignancies. Cancer and treatment-related cognitive changes cause distress, hinder resumption of normal routine and roles, and worsen quality of life. HCT differs from the delivery of chemotherapy in other cancer settings due to the intensity of chemotherapy and severity of toxicity. Older adults undergoing HCT are at high risk for cognitive decline and pervasive cognitive deficits. Interventions to improve cognitive outcomes are needed. The prevalence and risk of cognitive decline post-HCT are greater for older adults because of a greater number of existing health conditions (i.e., vascular disease) and impaired physical and psychologic function pre-HCT that can be exacerbated by treatment and the overall HCT experience. Exercise training improves cancer-related health outcomes, including cardiorespiratory fitness, inflammation, cancer related fatigue, depressive symptoms, and sleep disturbance. There is consistent evidence showing that physical activity improves cognitive function in older adults and survivors of other cancers. Improvement in cardiorespiratory fitness, brain structure, and inflammation underlie the mechanisms of the cognitive benefits of physical activity. While untested in older adults undergoing HCT, the investigator hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population. Physical activity improves the cognitive domains most affected by cancer treatment, namely executive function and working memory. Cognitive function is an important outcome to older adults and has not been a focus of physical activity interventions in the HCT population. In addition, older adults are underrepresented in previous physical activity interventions in the HCT population. The researcher will adapt CHAMPS II, an evidence-based physical activity intervention, to the HCT setting for older adults to improve cognitive function. CHAMPS II increased physical activity in sedentary older adults with multiple chronic health conditions. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. The program provides a foundation for application by including an instructor manual and directions for implementation. CHAMPS-II has been adapted and implemented in diverse communities using existing resources and improving contextual factors to increase physical activity for sedentary older adults. Adaptation of evidence-based interventions, such as CHAMPS-II, can result in an attenuation of effects if the core components are not maintained. However, adaptations can be made to fit the needs and priorities of the service setting, target audience, mode of delivery, and cultural context without compromising CHAMPS-II effectiveness. Through a research-practice partnership approach, the research team will help adapt the program while maintaining the core components of CHAMPS-II, develop new program materials, provide training, monitor implementation, and conduct program evaluation. The overarching goal is to enable HCT team members to implement CHAMPS-II and leverage existing organizational resources to enhance feasibility and sustainability. The research plan proposes a hybrid effectiveness-implementation design, which is a design that spans the effectiveness and implementation research to accelerate the translation of physical activity interventions into practice for older adults with cancer. This novel trial design will allow testing of the program within a randomized clinical trial methodology while observing and gathering information on implementation. The effectiveness study condition offers an ideal opportunity to examine implementation issues and plan for implementation strategies for a future study that examines both effectiveness and implementation strategies. The study will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework for planning and formative and process evaluation of the intervention. Formative and process evaluation provides information needed to evaluate an intervention's potential for translation into clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Multiple Myeloma, MDS, Myeloproliferative Neoplasm
Keywords
Hematopoietic cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Aim 1 will seek feedback from 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members for preliminary adaptation of the evidence-based physical activity intervention (CHAMPS-II) manual, and development of study materials. Aim 2 will iteratively adapt and implement CHAMPS-II for adults 60 years and older undergoing HCT with feedback from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members. Aim 3 will take the final CHAMPS-II adaptation from Aim 2 and pilot test it, using a Type 1 hybrid effectiveness-implementation design to determine its preliminary effectiveness to improve cognitive function compared to a wait-list control condition. Feedback will be obtained on the intervention and control condition from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members.
Masking
Outcomes Assessor
Masking Description
The outcomes assessor completing primary outcome testing during the RCT in Aim 3 will be blinded.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feedback for Preliminary Adaptation
Arm Type
No Intervention
Arm Description
Participants in Aim 1 will participate in qualitative interviews to obtain feedback on the CHAMPS-II intervention and survivorship education active control condition materials. Interviews will be with 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members.
Arm Title
Adapted CHAMPS-II intervention
Arm Type
Experimental
Arm Description
All participants in Aim 2 (preliminary testing) and Aim 3 (RCT) will participate in the CHAMPS-II physical activity program adapted to the HCT setting. Testing for outcome measures will be completed, and feedback on the intervention will be obtained via qualitative interviews from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members. Aim 3 participants will be randomized to either the immediate intervention (intervention then follow-up) or delayed intervention (wait period and then intervention).
Intervention Type
Behavioral
Intervention Name(s)
CHAMPS-II adapted to adults 60+ years in HCT setting
Intervention Description
CHAMPS-II is an evidence-based physical activity program designed to increase physical activity in sedentary older adults with multiple chronic health conditions. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. Participants will engage in progressive, light to moderate-intensity physical activity throughout the HCT process, with the support of physical therapists, physical activity counselors, and their care-partner. They will take part in supervised exercise sessions; unsupervised exercise sessions; counseling sessions to address barriers, motivators, goals, and safety; and receive telephone support. Walking is the primary mode of aerobic activity, with training in flexibility, strengthening and balance exercises also included. An exercise kit will be provided, consisting of an intervention workbook, therapeutic resistance bands, and activity logs.
Primary Outcome Measure Information:
Title
Change in executive function as measured by Trails A.
Description
Change in raw scores and z-scores, determined by the following neuropsychological test: Trail Making Test Part A (Trails A). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Time Frame
12 weeks
Title
Change in executive function as measured by Trails B.
Description
Change in raw scores and z-scores, determined by the following neuropsychological tests: Trail Making Test Part B (Trails B). Time to complete and number of errors are measured, where less time and errors are better outcomes.
Time Frame
12 weeks
Title
Change in executive function as measured by the Controlled Oral Word Association Test (COWAT).
Description
Change in raw scores and z-scores, determined by the following neuropsychological test: Controlled Oral Word Association Test (COWAT). Minimum score is zero and maximum is unlimited; higher score means better outcome.
Time Frame
12 weeks
Title
Change in working memory as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R).
Description
Change in raw scores and z-scores, determined by the following neuropsychological test: Hopkins Verbal Learning Test-Revised (HVLT-R). There are 3 learning trials and 1 delayed recall trial. Minimum score for each is zero and maximum is 12; higher score means better outcome. There is also a delayed recognition trial where person is presented with both true positives and false positives. Minimum score for both is zero and maximum is 12. For the true positives a higher score means better outcome. For the false positives a lower score means better outcome.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA).
Description
Change in total score, determined by objective measures of global cognitive function using the Montreal Cognitive Assessment (MoCA). Minimum score is zero and maximum is 30; higher score means better outcome.
Time Frame
12 weeks
Title
Change in subjective memory as measured by the Neuro-Quality of Life (QOL) Cognition Function-Short Form.
Description
Change in total score, determined by patient questionnaire: Neuro-Quality of Life (QOL) Cognition Function-Short Form. Minimum score is 8 and maximum score is 40; higher score means better outcome.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in functional ability as measured by the Short Performance Physical Battery (SPPB).
Description
Change in total score, determined by objective measures of balance, gait speed and endurance with the Short Performance Physical Battery (SPPB). Minimum score is zero, maximum is 12; higher score means better outcome.
Time Frame
12 weeks
Title
Change in endurance as measured by the 6-minute walk.
Description
Change in distance measured in meters, determined by a 6-minute walk. More distance in meters is better outcome.
Time Frame
12 weeks
Title
Change in performance of instrumental activities of daily living as measured by the Lawton Instrumental Activities of Daily Living (IADL).
Description
Change in total score, determined by a self-report questionnaire: Lawton Instrumental Activities of Daily Living (Lawton IADL). Minimum score is zero, maximum is 8; higher score means better outcome.
Time Frame
12 weeks
Title
Change in physical activity as measured by the Community Healthy Activities Model Program for Seniors II (CHAMPS-II) questionnaire.
Description
Change in total score of light and moderate physical activity as measured by a self-report questionnaire (CHAMPS-II questionnaire). Frequency and duration of various intensity activities and their caloric expenditure per week are all scored. No activity, duration or calories expended would be minimum score, and unlimited would be the maximum; where more frequency, duration and calories expended would be a better outcome.
Time Frame
12 weeks
Title
Change in physical activity as measured by the activePAL4 accelerometer data.
Description
Change in time spent in upright postural allocation as measured by an accelerometer (activPAL4). Increased time in upright postural allocation is better outcome.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Arm 1: Inclusion Criteria for Participants: age 60 years and older have a diagnosis of hematological malignancy have received autologous or allogeneic HCT within the prior 3-6 months able to speak and read English have provided written informed consent Exclusion Criteria for Participants: there are no exclusion criteria Inclusion Criteria for Participants' Care-Partner: age 19 years and older able to speak and read English Exclusion Criteria for Participants' Care-Partner: there are no exclusion criteria Inclusion Criteria for Transplant Team Member: age 19 years and older able to speak and read English Exclusion Criteria for Transplant Team Member: there are no exclusion criteria Arms 2 and 3: Inclusion Criteria for Participants: age 60 years and older have a diagnosis of hematological malignancy planned to receive an autologous or allogeneic HCT able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance) (In Arm 3 only): willingness to be randomized to either initiate the physical activity intervention pre-HCT or following Day 180 post-HCT, and to follow the protocol for the group to which they have been assigned able to speak and read English have provided written informed consent Exclusion Criteria for Participants: development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery) is not cleared to participate in exercise by a physician Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist: Myocardial infarctions in the past 3 months Resting or unstable angina Uncontrolled and/or serious arrhythmias 3rd degree heart block Acute congestive heart failure or ejection fraction <30% Clinically significant aortic stenosis Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon: o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition Inclusion Criteria for Participants' Care-Partner: age 19 years and older able to speak and read English able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance) have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form Exclusion Criteria for Participants' Care-Partner: development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery) is not cleared to participate in exercise by a physician Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist: Myocardial infarctions in the past 3 months Resting or unstable angina Uncontrolled and/or serious arrhythmias 3rd degree heart block Acute congestive heart failure or ejection fraction <30% Clinically significant aortic stenosis Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon: o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition Inclusion Criteria for Transplant Team Member: age 19 years and older able to speak and read English Exclusion Criteria for Transplant Team Member: there are no exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcia M Free, BSN
Phone
402-552-7623
Email
marcia.free@unmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thuy Koll, MD
Phone
402-559-7519
Email
thuy.koll@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thuy Koll, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thuy Koll, MD
Phone
402-559-7519
Email
thuy.koll@unmc.edu
First Name & Middle Initial & Last Name & Degree
Marcia M Free, RN
Phone
402-552-7623
Email
marcia.free@unmc.edu
First Name & Middle Initial & Last Name & Degree
Thuy Koll, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

We'll reach out to this number within 24 hrs